BILL NUMBER: SB 595 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 16, 1999
AMENDED IN SENATE JUNE 1, 1999
AMENDED IN SENATE APRIL 28, 1999
AMENDED IN SENATE APRIL 5, 1999
INTRODUCED BY Senator Speier
FEBRUARY 23, 1999
An act to amend , repeal, and add Section 2216 of the
Business and Professions Code, and to amend Sections 1248,
1248.1, 1248.15, 1248.2, and 1248.25 of , and to
amend, repeal, and add Section 1248 of, the Health and Safety
Code, relating to health care facilities.
LEGISLATIVE COUNSEL'S DIGEST
SB 595, as amended, Speier. Outpatient settings.
Existing law provides for the regulation of outpatient settings by
the Division of Licensing of the Medical Board of California.
Existing
Existing law defines an outpatient setting for purposes
of these provisions as any facility, clinic, unlicensed
clinic, center, office, or other setting that is not a part of a
general acute care facility and where designated anesthesia is used
in compliance with community standards in doses that when
administered have the probability of placing a patient at risk for
loss of the patient's life-preserving protective reflexes.
This bill would redefine outpatient setting for purposes of the
provisions regulating outpatient settings.
Existing law prohibits any physician and surgeon from performing
surgery in an outpatient setting using specified anesthesia unless
the setting is one of enumerated health care settings.
This bill would repeal these provisions as of November 1, 2000.
The bill would require the Medical Board of California to adopt
regulations establishing a new threshold standard for accreditation
of outpatient settings by November 1, 2000.
This bill would redefine outpatient setting. The bill would
prohibit a physician and surgeon from performing procedures in an
outpatient setting, as defined, using anesthesia, except as provided
for by the regulations adopted by the board pursuant to the bill and
in specified settings, and would make this provision operative on
November 1, 2000, only if the board adopts regulations pursuant to
the bill by that date. The bill would make an alternative provision
operative on November 1, 2000, if the board fails to adopt
regulations pursuant to the bill.
Existing law prohibits a person from operating an outpatient
setting unless the setting is one of enumerated health care settings.
This bill would make technical, nonsubstantive changes to these
provisions.
Existing law requires the division to adopt standards for the
accreditation of outpatient settings.
This bill would require outpatient settings to post, as designated
in the bill, a certificate of accreditation and the name and
telephone number of the accrediting agency with instructions on the
submission of complaints.
The bill would require outpatient settings and certain other
settings to have a minimum of 2 staff persons on the premises,
including one licensed health care professional, as long as a patient
who has not been discharged from supervised care is present. The
bill would require these settings to have a written discharge
criteria and would provide that the transfer of a patient who does
not meet discharge criteria shall constitute unprofessional conduct.
Existing law requires the division to notify the public, upon
inquiry, whether an outpatient setting is accredited, certified, or
licensed or whether the setting's accreditation, certification, or
license has been revoked.
This bill also would require the division to notify the public
pursuant to this provision about whether the outpatient setting's
accreditation, certification, or license has been denied for quality
of care reasons.
Existing law requires an accreditation agency to deny
accreditation to an outpatient setting that does not meet the
standards approved by the division and requires the accreditation
agency to notify the outpatient setting of the reasons for the
denial. Existing law authorizes an outpatient setting to reapply for
accreditation at any time after receiving notification of the
denial.
This bill also would require the accreditation agency to notify
the division of the reasons that an outpatient setting is denied
accreditation. The bill would authorize an outpatient setting to
reapply for accreditation at any time after receiving notification of
the denial.
Under existing law, the willful violation of these provisions
regulating outpatient settings is a misdemeanor.
Because this bill would change the requirements of outpatient
settings and accreditation agencies, it would change the definition
of an existing crime, thereby imposing a state-mandated local
program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 2216 of the Business and Professions
Code is amended to read: Professions Code is amended
to read:
2216. (a) On or after July 1, 1996, no physician and
surgeon shall perform procedures in an outpatient setting using
anesthesia, except local anesthesia or peripheral nerve blocks, or
both, complying with the community standard of practice, in doses
that, when administered, have the probability of placing a patient at
risk for loss of the patient's life-preserving protective reflexes,
unless the setting is specified in Section 1248.1. Outpatient
settings where anxiolytics and analgesics are administered are
excluded when administered, in compliance with the community standard
of practice, in doses that do not have the probability of placing
the patient at risk for loss of the patient's life-preserving
protective reflexes.
The
(b) The definition of "outpatient settings" contained in
subdivision (c) of Section 1248 shall apply to this section.
(c) The Medical Board of California shall adopt regulations
establishing a new threshold standard for accreditation of outpatient
settings by November 1, 2000.
(d) This section shall become inoperative on November 1, 2000,
and, as of January 1, 2001, is repealed, unless a later enacted
statute that is enacted before January 1, 2001, deletes or extends
the dates on which it becomes inoperative and is repealed.
SEC. 2. Section 2216 is added to the Business and Professions
code, to read:
2216. (a) No physician and surgeon shall perform procedures in an
outpatient setting using anesthesia, except as provided for by
regulations adopted by the Medical Board of California, unless the
setting is specified in Section 1248.1.
(b) The definition of "outpatient settings" contained in
subdivision (c) of Section 1248 of the Health and Safety Code shall
apply to this section.
(c) This section shall become operative on November 1, 2000, only
if the Medical Board of California adopts regulations establishing a
new threshold standard for accreditation of outpatient settings by
November 1, 2000.
SEC. 3. Section 2216 is added to the Business and Professions
Code, to read:
2216. (a) No physician and surgeon shall perform procedures in an
outpatient setting using anesthesia, including intravenous,
intramuscular, or rectal sedation or analgesia, unless the setting is
specified in Section 1248.1. Outpatient setting does not include
any setting where local anesthesia, minor blocks, or minimal oral
tranquilization are administered.
(b) On and after July November 1,
2000, no physician and surgeon shall perform procedures in an
outpatient setting using anesthesia, except local anesthesia, minor
blocks, or minimal oral tranquilization, unless the setting is
specified in Section 1248.1 of the Health and Safety Code.
(c) The definition of "outpatient settings" contained in
subdivision (c) of Section 1248 of the Health and Safety Code shall
apply to this section.
SEC. 2. Section 1248 of the Health and Safety Code is amended to
read:
(d) This section shall become operative only if the Medical Board
of California fails to adopt regulations establishing a new threshold
standard for accreditation of outpatient settings by November 1,
2000.
SEC. 4. Section 1248 of the Health and Safety Code is amended to
read:
1248. For purposes of this chapter, the following definitions
shall apply:
(a) "Division" means the Division of Licensing of the Medical
Board of California.
(b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
(c) "Outpatient setting" means any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia, except local anesthesia or peripheral nerve blocks, or
both, is used in compliance with the community standard of practice,
in doses that, when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving protective
reflexes.
"Outpatient setting" does not include, among other settings, any
setting where anxiolytics and analgesics are administered, when done
so in compliance with the community standard of practice, in doses
that do not have the probability of placing the patient at risk for
loss of the patient's life-preserving protective reflexes.
(d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.15 and 1248.4.
(e) The Medical Board of California shall adopt regulations
establishing a new threshold standard for accreditation of outpatient
settings by November 1, 2000.
(f) This section shall become inoperative on November 1, 2000,
and, as of January 1, 2001, is repealed, unless a later enacted
statute that is enacted before January 1, 2001, deletes or extends
the dates on which it becomes inoperative and is repealed.
SEC. 5. Section 1248 is added to the Health and Safety Code, to
read:
1248. For purposes of this chapter, the following definitions
shall apply:
(a) "Division" means the Division of Licensing of the Medical
Board of California.
(b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
(c) "Outpatient setting" means a facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia is used, subject to regulations adopted by the Medical
Board of California.
(d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.1 and 1248.4.
(e) This section shall become operative on November 1, 2000,
provided the Medical Board of California adopts regulations
establishing a new threshold standard for accreditation of outpatient
settings by November 1, 2000.
SEC. 6. Section 1248 is added to the Health and Safety Code, to
read:
1248. For purposes of this chapter, the following definitions
shall apply:
(a) "Division" means the Division of Licensing of the Medical
Board of California.
(b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
(c) "Outpatient setting" means any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia, including intravenous, intramuscular, or rectal sedation
or analgesia is administered.
"Outpatient setting" does not include any setting where local
anesthesia, minor blocks, or minimal oral tranquilization are
administered.
(d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.15 and 1248.4.
SEC. 3.
(e) This section shall become operative only if the Medical Board
of California fails to adopt regulations establishing a new threshold
standard for accreditation of outpatient settings by November 1,
2000.
SEC. 7. Section 1248.1 of the Health and Safety Code is
amended to read:
1248.1. No association, corporation, firm, partnership, or person
shall operate, manage, conduct, or maintain an outpatient setting in
this state, unless the setting is one of the following:
(a) An ambulatory surgical center that is certified to participate
in the Medicare program under Title XVIII (42 U.S.C. Sec. 1395 et
seq.) of the federal Social Security Act.
(b) Any clinic conducted, maintained, or operated by a federally
recognized Indian tribe or tribal organization, as defined in Section
450 or 1601 of Title 25 of the United States Code, and located on
land recognized as tribal land by the federal government.
(c) Any clinic directly conducted, maintained, or operated by the
United States or by any of its departments, officers, or agencies.
(d) Any primary care clinic licensed under subdivision (a) and any
surgical clinic licensed under subdivision (b) of Section 1204.
(e) Any health facility licensed as a general acute care hospital
under Chapter 2 (commencing with Section 1250).
(f) Any outpatient setting to the extent that it is used by a
dentist or physician and surgeon in compliance with Article 2.7
(commencing with Section 1646) or Article 2.8 (commencing with
Section 1647) of Chapter 4 of Division 2 of the Business and
Professions Code.
(g) An outpatient setting accredited by an accreditation agency
approved by the division pursuant to this chapter.
(h) A setting, including, but not limited to, a mobile van, in
which equipment is used to treat patients admitted to a facility
described in subdivision (a), (d), or (e), and in which the
procedures performed are staffed by the medical staff of, or other
healthcare practitioners with clinical privileges at, the facility
and are subject to the peer review process of the facility but which
setting is not a part of a facility described in subdivision (a),
(d), or (e).
(i) Nothing in this section shall relieve an association,
corporation, firm, partnership, or person from complying with all
other laws that are otherwise applicable.
SEC. 4.
SEC. 8. Section 1248.15 of the Health and Safety Code is
amended to read:
1248.15. (a) The division shall adopt standards for accreditation
and, in approving accreditation agencies to perform accreditation of
outpatient settings, shall ensure that the certification program
shall, at a minimum, include standards for the following aspects of
the settings' operations:
(1) Outpatient setting allied health staff shall be licensed or
certified to the extent required by state or federal law.
(2) (A) Outpatient settings shall have a system for facility
safety and emergency training requirements.
(B) There shall be onsite equipment, medication, and trained
personnel to facilitate handling of services sought or provided and
to facilitate handling of any medical emergency that may arise in
connection with services sought or provided.
(C) In order for procedures to be performed in an outpatient
setting as defined in Section 1248, the outpatient setting shall do
one of the following:
(i) Have a written transfer agreement with a local accredited or
licensed acute care hospital, approved by the facility's medical
staff.
(ii) Permit surgery only by a licensee who has admitting
privileges at a local accredited or licensed acute care hospital,
with the exception that licensees who may be precluded from having
admitting privileges by their professional classification or other
administrative limitations, shall have a written transfer agreement
with licensees who have admitting privileges at local accredited or
licensed acute care hospitals.
(iii) Submit for approval by an accrediting agency, a detailed
procedural plan for handling medical emergencies that shall be
reviewed at the time of accreditation. No reasonable plan shall be
disapproved by the accrediting agency.
(D) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body, the Health Care Financing
Administration, the State Department of Health Services, and the
appropriate licensing authority.
(3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of the Business and Professions Code
or physician and surgeon, osteopathic physician and surgeon, or
podiatrist acting within his or her scope of practice under Chapter 5
(commencing with Section 2000) of the Business and Professions Code
or the Osteopathic Initiative Act. The outpatient setting may, in
its discretion, permit anesthesia service by a certified registered
nurse anesthetist acting within his or her scope of practice under
Article 7 (commencing with Section 2825) of Chapter 6 of the Business
and Professions Code.
(4) Outpatient settings shall have a system for maintaining
clinical records.
(5) Outpatient settings shall have a system for patient care and
monitoring procedures.
(6) (A) Outpatient settings shall have a system for quality
assessment and improvement.
(B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
(C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
(7) Outpatient settings regulated by this chapter that have
multiple service locations governed by the same standards may elect
to have all service sites surveyed on any accreditation survey.
Organizations that do not elect to have all sites surveyed shall have
a sample, not to exceed 20 percent of all service sites, surveyed.
The actual sample size shall be determined by the division. The
accreditation agency shall determine the location of the sites to be
surveyed. Outpatient settings that have five or fewer sites shall
have at least one site surveyed. When an organization that elects to
have a sample of sites surveyed is approved for accreditation, all
of the organizations' sites shall be automatically accredited.
(8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
(9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
(10) Outpatient settings shall have written discharge criteria.
(b) Outpatient settings, as defined in subdivision (c) of Section
1248, shall have a minimum of two staff persons on the premises, one
of whom shall be a licensed health care professional, as long as a
patient who has not been discharged from supervised care is present.
These settings shall have written discharge criteria. The transfer
of a patient who does not meet the discharge criteria to an
unlicensed setting shall constitute unprofessional conduct.
(c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the division to protect the public health and safety.
(d) No accreditation standard adopted or approved by the division,
and no standard included in any certification program of any
accreditation agency approved by the division, shall serve to limit
the ability of any allied healthcare practitioner to provide services
within his or her full scope of practice. Notwithstanding this or
any other provision of law, each outpatient setting may limit the
privileges, or determine the privileges, within the appropriate scope
of practice, that will be afforded to physicians and allied health
care practitioners who practice at the facility, in accordance with
credentialing standards established by the outpatient setting in
compliance with this chapter. Privileges may not be arbitrarily
restricted based on category of licensure.
SEC. 5.
SEC. 9. Section 1248.2 of the Health and Safety Code is
amended to read:
1248.2. (a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the division under this chapter.
(b) The division shall obtain and maintain a list of all
accredited, certified, and licensed outpatient settings from the
information provided by the accreditation, certification, and
licensing agencies approved by the division, and shall notify the
public, upon inquiry, whether a setting is accredited, certified, or
licensed, or whether the setting's accreditation, certification, or
license has been denied for quality of care reasons or revoked.
SEC. 6.
SEC. 10. Section 1248.25 of the Health and Safety Code is
amended to read:
1248.25. If an outpatient setting does not meet the standards
approved by the division, accreditation shall be denied by the
accreditation agency, which shall provide the outpatient setting and
the division with notification of the reasons for the denial. An
outpatient setting may reapply for accreditation at any time after
receiving notification of the denial.
SEC. 7.
SEC. 11. No reimbursement is required by this act pursuant
to Section 6 of Article XIIIB of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIIIB of the California Constitution.